(92 days)
No
The device description and performance studies focus on the material properties, mechanical performance, and biocompatibility of a dental implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a dental implant system intended for use in partially or fully edentulous mandibles and maxillae, in support of various dental restorations. This aligns with the definition of a therapeutic device as it is designed to treat a medical condition (edentulism) by replacing missing teeth and restoring function.
No
The device is a dental implant system intended for surgical placement in the bone to support restorations, not to diagnose a condition.
No
The device description explicitly states it is a dental implant made of titanium metal intended for surgical placement, which is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgically implanted device used to support dental restorations in the jawbone. This is a direct medical intervention, not a test performed on samples taken from the body.
- Device Description: The description details a dental implant made of titanium, designed for surgical placement. This aligns with a medical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Reagents, calibrators, or controls
The device is clearly a surgically implanted medical device used for structural support in dental procedures.
N/A
Intended Use / Indications for Use
The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Product codes
DZE
Device Description
The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile.
The OneQ-SL s-Clean Implant system diameter and lengths are below:
- . The OneO-SL s-Clean Fixtures
Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:
| Division | Platform Diameters
(Fixture Diameters) | Body Diameters | Lengths |
|---|---|---|---|
| Regular | Ø3.7 | Ø3.5 | 7, 8, 10, 12, 14 mm |
| | Ø3.9 | Ø3.6 | |
The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was performed for this submission.
Non-Clinical Test Data:
Below tests were performed for predicate devices and leveraged for the subject device:
- Gamma Sterilization Validation Test according to ISO11137-1,- 2 referenced in K153639 and . K161244
- . Shelf life Validation Tests referenced in K153639 and K161244
- Tensile Test according to ASTM D882 -
- । Seal Peeling Test according to ASTM F88
- Burst Test according to ASTM F1140 -
- Dye penetration Test according to ASTM F1929 -
- -Bubble Test according to ASTM F2096
- Fatigue Test according to ISO 14801:2007 referenced in K150344 and K153639 .
- Biocompatibility Test referenced in K161244
- Cytotoxicity according to ISO10993-5 -
- Sensitization according to ISO10993-10 -
- Irritation according to ISO10993-10 -
- Acute systemic toxicity according to ISO 10993-11 -
- -Implantation according to ISO 10993-6
- Genotoxicity according to ISO 10993-3 -
- Subchronic Toxicity according to ISO 10993-11 and ISO 10993-6 -
- Biocompatibility Test referenced in K161244
- . Endotoxin Test according to USP referenced in K161244
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K073486, K082843, K111364, K150344 (Note: K150344 is listed as both a predicate and a reference device as per the tables provided.)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K170220
Trade/Device Name: OneQ-SL s-Clean Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2017 Received: April 19, 2017
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left, resembling a flame or a stylized letter 'D'. To the right of the shape is the word "DENTIS" in a bold, sans-serif font. The overall design is clean and modern.
Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Indication for Use
Device Name: OneO-SL s-Clean Implant System
Indication for Use:
The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
3
510(K) Summary
Submitter
Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
Device Information
Trade Name: OneQ-SL s-Clean Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 04/13/2017
Official Correspondent
Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122
Description
The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the predicate device, OneQ-SL s-Clean Implant System (K153639). This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.
The OneQ-SL s-Clean Implant system diameter and lengths are below:
- . The OneO-SL s-Clean Fixtures
Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:
| Division | Platform Diameters
(Fixture Diameters) | Body Diameters | Lengths |
|----------|-------------------------------------------|----------------|---------------------|
| Regular | Ø3.7 | Ø3.5 | 7, 8, 10, 12, 14 mm |
| | Ø3.9 | Ø3.6 | |
The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This
4
system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.
Indication for Use
The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate devices:
- K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
- . K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd.
- . K150344, Dentis Dental Implant System by Dentis Co., Ltd.
| Division | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Device Name | OneQ-SL s-Clean | |||
| Implant System | OneQ-SL s-Clean | |||
| Implant System | s-Clean OneQ-SL | |||
| Narrow Implant | ||||
| System | Dentis Dental Implant | |||
| System | ||||
| 510(k) Number | N/A | K153639 | K161244 | K150344 |
| Manufacturer | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. | DENTIS CO., LTD. |
| Material | Ti-6Al-4V-ELI | |||
| CP Titanium Gr.4 | CP Titanium Gr.4 | Ti-6Al-4V-ELI | CP Titanium Gr.4 | |
| Design | ||||
| (Fixture Type) | • Internal Hex- | |||
| connected | ||||
| • Submerged Fixture | ||||
| • Bone level | ||||
| • Tapered & straight | ||||
| body | ||||
| • 3 sided cutting edge | ||||
| with self-tapping | • Internal Hex- | |||
| connected | ||||
| • Submerged Fixture | ||||
| • Bone level | ||||
| • Tapered & straight | ||||
| body | ||||
| • 3 sided cutting edge | ||||
| with self-tapping | • Internal double hex | |||
| connection | ||||
| • Straight and | ||||
| tapered implant | ||||
| body | ||||
| • 3 sided cutting edge | ||||
| of bottom and bone | ||||
| level design | • Internal Hex- | |||
| Connected | ||||
| • Submerged Fixture | ||||
| • Bone level, Tapered | ||||
| body | ||||
| • 4 sided cutting edge | ||||
| with self-tapping | ||||
| Fixture | ||||
| Diameter | Ø3.7, Ø3.9 | Ø3.7, Ø3.9, Ø4.2, | ||
| Ø4.7, Ø5.2 | Ø 3.0, Ø 3.3, Ø 3.7 | Ø3.7, Ø4.1, Ø4.3, | ||
| Ø4.8 | ||||
| Fixture Length | 7, 8, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm | 8, 10, 12, 14 mm | 7, 8, 10, 12, 14 mm |
| Surface | ||||
| Treatment | SLA | SLA | SLA | RBM |
| Gamma | ||||
| Sterilized | Yes | Yes | Yes | Yes |
| Product Code | DZE | DZE, NHA | DZE, NHA | DZE, NHA |
| Shelf Life | 8 years | 1 year | 8 years | 5 years |
5
| Indication for
use | The OneQ-SL s-Clean
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple unit
restorations including;
cemented retained,
screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed | The OneQ-SL s-Clean
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple unit
restorations including;
cemented retained,
screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed | The s-Clean OneQ-
SL Narrow Implant
System (3.0, 3.3mm)
may be used as an
artificial root
structure for single
tooth replacement of
mandibular central
and lateral incisors
and maxillary lateral
incisors.
The implants may be
restored immediately
- with a temporary
prosthesis that is not
in functional
occlusion, - when splinted
together as an
artificial root
structure for multiple
tooth replacement of
mandibular incisors,
or - for denture
stabilization using
multiple implants in
the anterior mandible
and maxilla.
The implants may be
placed in immediate
function when good
primary stability has
been achieved and
with appropriate
occlusal loading. | The Dentis Dental
Implant System is
indicated for use in
partially or fully
edentulous mandibles
and maxillae, in
support of single or
multiple-unit
restorations
including; cemented
retained, screw
retained, or
overdenture
restorations, and
terminal or
intermediate
abutment support for
fixed bridgework.
This system is
dedicated for one and
two stage surgical
procedures and not
dedicated for
immediate loading.
This system is
intended for delayed
loading. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | bridgework. This
system is dedicated for
one and two stage
surgical procedures.
This system is
intended for delayed
loading. | bridgework. This
system is dedicated for
one and two stage
surgical procedures.
This system is
intended for delayed
loading. | | |
6
K170220
Substantial Equivalence Discussion
The subject device shares identical Indications for Use statement as the primary predicate device (K153639). The technological features of the subject device differ from the primary predicate in the following ways:
- Addition of 3.7mm and 3.9mm diameter of Implants made of Ti-6A1-4V (ELI)
- . 8 years of Shelf Life
The reference predicates, s-Clean OneQ-SL Narrow Implant System (K161244) and dentis dental implant system (K153639), support substantial equivalence of the addition of 3.7mm and 3.9mm diameter of Implants with different material and shelf life.
Non-Clinical Test Data
.
Below tests were performed for predicate devices and leveraged for the subject device:
- Gamma Sterilization Validation Test according to ISO11137-1,- 2 referenced in K153639 and . K161244
- . Shelf life Validation Tests referenced in K153639 and K161244
- Tensile Test according to ASTM D882 -
- । Seal Peeling Test according to ASTM F88
- Burst Test according to ASTM F1140 -
- Dye penetration Test according to ASTM F1929 -
- -Bubble Test according to ASTM F2096
- Fatigue Test according to ISO 14801:2007 referenced in K150344 and K153639 .
- Biocompatibility Test referenced in K161244
- Cytotoxicity according to ISO10993-5 -
- Sensitization according to ISO10993-10 -
- Irritation according to ISO10993-10 -
- Acute systemic toxicity according to ISO 10993-11 -
- -Implantation according to ISO 10993-6
- Genotoxicity according to ISO 10993-3 -
- Subchronic Toxicity according to ISO 10993-11 and ISO 10993-6 -
- Biocompatibility Test referenced in K161244
- . Endotoxin Test according to USP referenced in K161244
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.
Summary of clinical testing
No clinical testing was performed for this submission.
7
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the OneQ-SL s-Clean Implant System is substantially equivalent to the predicate devices as described herein.